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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Model Number 24653
Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2023
Event Type  malfunction  
Event Description
It was reported that the stent was partially deployed.An eluvia drug-eluting vascular stent system 6x60, 130 cm was selected for use in the procedure.During device preparation, when the device packaging was opened, it was observed the stent was deployed by approximately one cm, despite the thumbwheel lock being in place.The eluvia drug-eluting vascular stent system was discarded and replaced with another eluvia drug-eluting vascular stent system.The procedure was successfully completed using the new device and there were no reported patient complications.
 
Manufacturer Narrative
Updated fields: h6 - device codes: the device code has been updated from a15 to a150103 to better reflect the reported event.
 
Event Description
It was reported that the stent was partially deployed.An eluvia drug-eluting vascular stent system 6x60, 130 cm was selected for use in the procedure.During device preparation, when the device packaging was opened, it was observed the stent was deployed by approximately one cm, despite the thumbwheel lock being in place.The eluvia drug-eluting vascular stent system was discarded and replaced with another eluvia drug-eluting vascular stent system.The procedure was successfully completed using the new device and there were no reported patient complications.
 
Event Description
It was reported that the stent was partially deployed.An eluvia drug-eluting vascular stent system 6x60, 130 cm was selected for use in the procedure.During device preparation, when the device packaging was opened, it was observed the stent was deployed by approximately one cm, despite the thumbwheel lock being in place.The eluvia drug-eluting vascular stent system was discarded and replaced with another eluvia drug-eluting vascular stent system.The procedure was successfully completed using the new device and there were no reported patient complications.
 
Manufacturer Narrative
Device analysis: returned product consisted of an eluvia self-expanding stent system.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.The stent was partially deployed 7mm from the middle sheath.Microscopic examination revealed no additional damages.The thumbwheel lock and pull rack were still in the manufactured position.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that could have contributed to the deployment issue.Updated fields: h6 - device codes: the device code has been updated from a15 to a150103 to better reflect the reported event.
 
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Brand Name
ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17737043
MDR Text Key323284944
Report Number2124215-2023-49665
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24653
Device Catalogue Number24653
Device Lot Number0031072621
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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